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临床试验/NCT06131593
NCT06131593已完成不适用

TAP Block With Dexamethasone Versus TAP Block With Methyl-prednisolone as a Pain Treatment Modality After Total Abdominal Hysterectomy Procedures: Randomized Controlled Trial

Kasr El Aini Hospital1 个研究点 分布在 1 个国家目标入组 50 人开始时间: 2023年12月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
50
试验地点
1
主要终点
postoperative pain score by Visual analogue score at 48 hrs.

研究概览

简要总结

The aim of this work to compare between the efficacy of ultrasound guided TAP block with dexamethasone as an adjuvant versus ultrasound guided TAPB with methyl prednisolone as an adjuvant to local anesthetic for postoperative pain management in lower abdominal hysterectomy procedures.

详细描述

Patients will be divided in to two groups; TAPB with dexamethasone as an adjuvant to local anesthetic Gr A(n=25) and TAPB with methyl prednisolone as an adjuvant to local anesthetic Gr B(n=25).

By the end of surgery and with the patient in supine position and after covering of surgery site, preparing the skin with povidone iodine, a high frequency (5-10 MHZ) ultrasound probe (S-NerveTM; SonoSite Inc., Bothell, WA, USA) will be placed transversally on abdominal wall between lower costal margin and iliac crest near midline. After identifying the rectus abdominis muscle, we will gradually move the ultrasound probe laterally to identify the transversus abdominis muscle lying posterior to the rectus muscle. A 22 G echogenic needle using the in plane technique will be inserted medially aiming towards the iliac crest, then 30ml total volume of 0.25 plain bupivacaine 1.5mg/kg with lidocaine 1% 3mg/kg with 8mg dexamethasone in group A patients and 30ml total volume of 0.25 plain bupivacaine 1.5mg/kg with lidocaine 1% 3mg/kg with 50 mg methylprednisolone in group B patients.

Vital signs (H.R and non invasive blood pressure) will be recorded at the onset of the block then every 20 min for an hour then every 4hrs for 12 hrs. post operative

Postoperative:

Paracetamol every 8 hours and ketorolac every 12 hours should be given as a part of multimodal analgesia and nalbuphine given as rescue analgesia and included in secondary outcomes

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
Double (Participant, Outcomes Assessor)

盲法说明

The patient and assessing study outcomes will be blinded to the study group allocation.

入排标准

年龄范围
20 Years 至 45 Years(Adult)
性别
Female
接受健康志愿者

入选标准

  • ASA physical status I-II.
  • Age 20-45 years.
  • Undergoing lower abdominal hysterectomies.

排除标准

  • Patient refusal
  • Patients with coagulopathy.
  • Hypertensive patients.
  • Diabetic patients.
  • Morbid obesity
  • Allergy to the used drugs

研究组 & 干预措施

Group TAPB-D (n=25)

Experimental

Patients in this group will receive TAPB with dexamethasone as an adjuvant to local anesthetic.

干预措施: TAPB with dexamethasone as an adjuvant to local anesthetics (Drug)

Group TAPB-M (n=25)

Active Comparator

Patients in this group will receive TAPB with methylprednisolone as an adjuvant to local anesthetic.

干预措施: TAPB with methylprednisolone as an adjuvant to local anesthetics (Drug)

结局指标

主要结局

postoperative pain score by Visual analogue score at 48 hrs.

时间窗: 48 hours

postoperative pain score by Visual analogue score at 48 hours Post operative pain assessment using Visual analogue score which is numerical score from (0-10) (zero refer to no pain and 10 refer to the worst pain)

次要结局

  • Time to first analgesic request of rescue analgesia(24 hours)
  • Total consumption of Nalbuphine in 1st 24 hours(24 hours)

研究者

发起方
Kasr El Aini Hospital
申办方类型
Other
责任方
Principal Investigator
主要研究者

Khaled Abdelfattah Abdallah Sarhan

principal investigator, Asst. professor of anesthesia, Cairo university

Kasr El Aini Hospital

研究点 (1)

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